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Category: Audit
MDR (EU) 2017/745 is a set of regulations that govern the European medical device market. It was created […]
Check out our latest video and let us know what you think!
We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide […]
I’ve recently returned from a visit to our offices in China where I was able to attend a […]
Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry. A common question […]
ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical […]
Although the program started in 2001, there continues to be a lack of understanding regarding what C-TPAT is […]
We saw this video posted recently and thought it was such an excellent introduction to audits that we […]
A previous Quality Q & A newsletter article featured tips for audit preparation. In the reprinted content below, […]
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